Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers

March 24, 2026 updated by: Nicole Matthews, Ph.D.

The goal of this clinical trial is to learn whether a mindfulness-based intervention can reduce depression and anxiety in autistic adolescents. The main question this trial aims to answer is: Do adolescents who complete MINDful TIME show reductions in depression and anxiety compared to an active control group? Researchers will compare adolescents who complete MINDful TIME to adolescents who are instructed to use a mindfulness meditation mobile-app to see if changes in anxiety and depression differ between the two groups.

Participants will either:

  • Attend weekly 90-minute MINDful TIME group meetings through Zoom with their parent or caregiver for a total of 8-weeks and use a mindfulness meditation app daily, or
  • Use a mindfulness meditation app daily for 8-weeks

All participants will:

  • Attend virtual intake, baseline, and follow-up visits to complete data collection
  • Complete a weekly electronic meditation diary

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Southwest Autism Research & Resource Center
        • Contact:
        • Principal Investigator:
          • Nicole L Matthews, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adolescents must be ages 13 to 18 years
  • Formal clinical or educational ASD diagnosis confirmed by the study team (i.e., review of formal diagnostic report from the diagnosing practitioner or Multidisciplinary Evaluation Team report (MET) shared with the research team by the family) )
  • Must be willing to be randomized to a treatment or delayed treatment control group
  • Must be able to attend at least 7 of the 8 group meetings
  • English speaking: Adolescents and their parent/caregivers must be English-speaking because the screening and behavioral measures are in English, as well as the intervention content

Exclusion Criteria:

  • Non-verbal participants will be excluded to ensure test compliance and increase sample homogeneity.
  • Participants with IQ scores <70 will be excluded because the intervention was developed for individuals without intellectual disability.
  • Participants with a physical disability or co-occurring condition that may prevent participation in the weekly group meetings (e.g., selective mutism; aggressive behavior; inability to participate in a 90-minute video conference meeting each week)
  • Participants who report active suicidal ideation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MINDful TIME Intervention
Behavioral: MINDful TIME
The intervention will include weekly 90-minute group meetings held online through Zoom. Adolescents and parents will meet in separate groups and will learn about mindfulness-based strategies that can be used to manage and reduce stress, anxiety, and depression. They will also learn evidence-based strategies to complete daily guided mindfulness meditations using Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for 5-20 minutes each day during and after the 8-week intervention.
Active Comparator: Mindfulness Mobile App
Behavioral: Mindfulness Mobile App
Participants will receive access to the Happier app and brief instruction in Habit Formation strategies at the start of their intervention period. A trained member of the research team will provide participants instructions for anchoring their mindfulness meditation to a pre-existing habit (i.e., their morning bathroom routine). Like the treatment group, participants will be encouraged to meditate using the mobile app for 5-20 minutes each day during and after the 8-week intervention period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in Children's Depression Inventory (CDI) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent-report measure of adolescent depressive symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of depression symptoms.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Adolescent-report measure of mindfulness. Scores range from 0 to 40 with higher scores indicating higher levels of mindfulness.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in Center for Epidemiological Studies Depression Scale (CESD-D)
Time Frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Adolescent-report measure of depression. 20-item scale with scores ranging from 0 to 60. Higher scores indicate higher depression symptoms.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent-report measure of adolescent executive function and self-regulation. Scores range from 30 to 90, with higher scores indicating higher levels of executive dysfunction.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent self-report measure of mindfulness on observation, description, aware actions, non-judgmental inner experience, and non-reactivity. Factor scores range from 1 to 5, with higher scores indicating higher levels of mindfulness.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent-report measure of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. Percentile scores range from 0 to 99, with higher scores indicating higher levels of parenting stress.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Adolescent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent self-report measure on current well-being. Scores range from 0 to 100, with higher scores indicating better quality of life.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nicole Matthews, Ph.D.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Arizona State University
Southwest Autism Research & Resource Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicole Matthews, Ph.D., Southwest Autism Research & Resource Center
  • Principal Investigator: Blair Braden, Ph.D., Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00023487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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